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Standard ČSN EN ISO 20387 1.6.2021 preview

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ČSN EN ISO 20387 (010107)

Biotechnology - Biobanking - General requirements for biobanking

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STANDARD published on 1.6.2021


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The information about the standard:

Designation standards: ČSN EN ISO 20387
Classification mark: 010107
Catalog number: 512455
Publication date standards: 1.6.2021
SKU: NS-1026209
The number of pages: 56
Approximate weight : 168 g (0.37 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Biology. Botany. Zoology

Annotation of standard text ČSN EN ISO 20387 (010107):

Tento dokument specifikuje obecné požadavky na kompetenci, nestrannost a konzistentní provoz bio bank, včetně požadavků na kontrolu kvality tak, aby bylo zajištěno, že soubory biologického materiálu a dat budou mít odpovídající kvalitu. Tento dokument je použitelný pro všechny organizace provozující biobanky, včetně biobank biologického materiálu z mnohobuněčných organismů (např. lidí, zvířat, hub a rostlin) a mikroorganismů pro výzkum a vývoj. Uživatelé biobank, regulační orgány, organizace a programy využívající vzájemné posouzení, akreditační orgány a další, mohou též používat tento dokument k potvrzení nebo uznání kompetence biobank. Tento dokument se nevztahuje na biologický materiál určený k výrobě potravin/krmiv, pro laboratoře provádějící analýzy pro výrobu potravin/krmiv a/nebo na terapeutické použití. POZNÁMKA 1 - Na konkrétní témata zahrnutá v tomto dokumentu se mohou také vztahovat mezinárodní, národní nebo regionální předpisy nebo požadavky. POZNÁMKA 2 - Subjekty, které nakládají s lidským materiálem získaným a používaným pro diagnostické a léčebné účely, by se měly řídit především ISO 15189 a dalšími klinickými standardy

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